Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD

Inclusion Criteria

• Male or female aged 18 to 60 years, inclusive at the time of Screening.
• Diagnosed with ADHD using the DSM-5 criteria based on the Adults ADHD Clinical Diagnostic Scale (ACDS).
• IQ within normal range based upon clinical opinion of the Investigator.
• Baseline AISRS total score greater than or equal to 26.
• Baseline score of 4 or higher in CGI-S.
• Females who participate in this study will be of childbearing or non-childbearing potential:
• Childbearing potential: Physically capable of becoming pregnant
• Non-childbearing potential:
• Permanently sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation for at least 6 weeks or documented successful hysteroscopic sterilization); and/or
• Post-menopausal (no menstrual period for at least 12 consecutive months without any other medical cause).
• Females of childbearing potential must be non-lactating and must have a negative serum pregnancy test at Screening.
• Willing to use acceptable, effective methods of contraception.
• Be able to attend the clinic regularly and reliably.
• Be able to understand, read, write, and speak English fluently to complete the study related materials.
• Be informed of the nature of the study and give written consent prior to any study procedure.

Exclusion Criteria

• Current or lifetime history of bipolar disorder or any psychotic disorder as established by Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0.2.
• Current history of major depression, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, or post-traumatic stress disorder as established by the M.I.N.I. 7.0.2.
• Known history of chronic medical illnesses including untreated thyroid disease, peripheral vasculopathy, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, and known family history of sudden death.
• History of uncontrolled hypertension or a resting systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg. Subjects with well-controlled hypertension on a stable dose for at least 3 months of anti-hypertensives will be allowed to participate.
• Have clinically significant findings in vital signs measurements at Screening including:
• Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg
• Heart rate >100 bpm
• Known history or presence of significant renal or hepatic disease, as indicated by clinical laboratory assessment:
• Liver function test results ≥2 times the upper normal limit
• Abnormal blood urea nitrogen, or creatinine levels
• Clinically significant abnormal electrocardiogram or cardiac findings on physical examination (including the presence of a pathologic murmur).
• Use of the following medications within 14 days of Baseline Visit:
• Atomoxetine
• Monoamine oxidase inhibitors (e.g., selegiline, isocarboxazid, phenelzine, tranylcypromine)
• Tricyclic antidepressants (e.g., desipramine, protriptyline).
• Use of the following medications within 3 days of Baseline Visit:
• Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid hydrochloride [HCl], ascorbic acid)
• Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).
• Use of fluoxetine within 30 days of Baseline Visit.
• Use of stimulant medications within 1 week of Baseline Visit.
• Planned use of prohibited drugs or agents from the Screening visit through the end of the study.
• Participation in a clinical study in which an investigational drug was administered within 30 days prior to Screening.
• Abnormal clinically significant laboratory test values at Screening that, in the opinion of the Medical Monitor or Sponsor, would preclude study participation.
• Known history of allergy/hypersensitivity to amphetamine or any of the components of AMPH ER TAB.
• Known history of lack of clinical response to amphetamine based upon Investigator judgment.
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